Bamlanivimab (Page 5 of 12)

2.4 Dose Preparation and Administration

General Information

• Bamlanivimab and etesevimab solution for infusion should be prepared by a qualified healthcare professional using aseptic technique.
• Bamlanivimab and etesevimab are supplied in individual vials but are administered together.
• Inspect bamlanivimab and etesevimab vials visually for particulate matter and discoloration. Bamlanivimab and etesevimab are clear to opalescent and colorless to slightly yellow to slightly brown solutions.
• The prepared infusion solution should not be administered simultaneously with any other medication. The compatibility of bamlanivimab and etesevimab injection with IV solutions and medications other than 0.9% Sodium Chloride Injection is not known.
• If the infusion must be discontinued due to an infusion reaction, discard any unused product.
• The use of closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport with bamlanivimab and etesevimab has not been studied.
• Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.

IV Infusion in Adults (≥18 years regardless of weight) and Pediatric Patients (<18 years and weighing at least 40 kg)

Materials Needed

• 1 bamlanivimab vial (700 mg/20 mL)
• 2 etesevimab vials (700 mg/20 mL)
• 1 polyvinyl chloride (PVC) or polyethylene (PE)-line PVC, sterile prefilled infusion bag containing 0.9% Sodium Chloride Injection (sizes 50 mL to 250 mL)
• 1 PVC or PE-lined PVC infusion set
• 1 in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter
• 0.9% Sodium Chloride for flushing tubing

Preparation

• Remove 1 bamlanivimab vial and 2 etesevimab vials from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake the vials. Inspect vials.
• Withdraw 20 mL from one bamlanivimab vial and 40 mL from two etesevimab vials and inject all 60 mL into a prefilled infusion bag containing 0.9% Sodium Chloride (see Table 1).
• Discard any product remaining in the vials.
• Gently invert the bag by hand approximately 10 times to mix. Do not shake.

Table 1: Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusion^a in Adults (≥18 years regardless of weight) and Pediatric Patients (<18 years and weighing at least 40 kg)

a 700 mg of bamlanivimab and 1,400 mg of etesevimab are added to the same infusion bag and administered together as a single intravenous infusion.
b The minimum infusion time for patients weighing at least 40 kg and less than 50 kg who are administered bamlanivimab and etesevimab diluted in a 250-mL prefilled 0.9% Sodium Chloride infusion bag must be extended to at least 70 minutes to reduce endotoxin load.
Drug a : Add 20 mL of bamlanivimab (1 vial) and 40 mL of etesevimab (2 vials) for a total of 60 mL to a prefilled infusion bag and administer as instructed below
Size of Prefilled 0.9% Sodium Chloride Infusion Bag	Maximum Infusion Rate	Minimum Infusion Time
50 mL	310 mL/hr	21 minutes
100 mL	310 mL/hr	31 minutes
150 mL	310 mL/hr	41 minutes
250 mLFor patients weighing at least 50 kg	310 mL/hr	60 minutes
250 mLb For patients weighing ≥40 kg and <50 kg	266 mL/hr	70 minutes

Administration

• These products are preservative-free and therefore, the diluted infusion solution should be administered immediately.
  • If immediate administration is not possible, store the diluted infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) and up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes prior to administration.
• Attach the infusion set to the IV bag. Use of in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter is strongly recommended.
• Prime the infusion set.
• Administer the entire infusion solution in the bag via pump or gravity according to the size of infusion bag used (see Table 1). Due to potential overfill of prefilled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage.
• Once infusion is complete, flush the tubing with 0.9% Sodium Chloride to ensure delivery of the required dose.

IV Infusion in Pediatric Patients (<18 years and weighing <40 kg)

Materials Needed

IV bag	Syringe Pump
1 bamlanivimab vial (700 mg/20 mL)	1 bamlanivimab vial (700 mg/20 mL)
1 etesevimab vial (700 mg/20 mL)	1 etesevimab vial (700 mg/20 mL)
1 sterile, empty 50-mL PVC or PE-lined PVC infusion bag	1 disposable syringe
1 PVC or PE-lined PVC Infusion set	1 syringe extension set
1 in-line or add-on 0.2/0.22 micron PES filter	1 syringe pump
0.9% Sodium Chloride for flushing	0.9% Sodium Chloride for flushing

Under this EUA, single-dose vials may be used to prepare more than one pediatric dose; in addition, pediatric doses do not need to be diluted for patients <18 years and weighing <40 kg.

Preparation

• Remove bamlanivimab and etesevimab vials from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake vials. Inspect vials.
• Withdraw appropriate amounts of bamlanivimab and etesevimab from vials based on body weight and inject into the empty infusion bag or draw into a disposable syringe (see Table 2).
  • Multiple doses of bamlanivimab and etesevimab may be prepared from each product vial (see the storage conditions specified below). Prepare all infusion bags or syringes at the same time. Appropriately label any prepared doses including the patient weight and dose, and time of preparation to minimize risk of medication errors, particularly in cases where multiple doses are prepared simultaneously.
  • Discard any product remaining in the vials after all doses have been prepared.
• Gently invert the infusion bag or syringe to mix the contents. Do not shake or vigorously agitate.

Table 2: Recommended Dosing, Preparation and Administration Instructions for Undiluted Bamlanivimab (BAM) and Etesevimab (ETE) for IV Infusion in Pediatric Patients (<18 years and weighing less than 40 kg)

a Amount of BAM (as mL) and amount of ETE (as mL) for patients weighing up to 12 kg are calculated and rounded to one decimal place.
Body Weight	BAM/ETE dose(mg)	Amount of BAM(as mL) a	Amount of ETE(as mL) a	Maximum Infusion Rate
>20 kg to <40 kg	350 mg / 700 mg	10 mL	20 mL	1.88 mL/min
>12 kg to 20 kg	175 mg / 350 mg	5 mL	10 mL	0.94 mL/min
>11 kg to 12 kg	138 mg / 276 mg	3.9 mL	7.9 mL	0.74 mL/min
>10 kg to 11 kg	126 mg / 252 mg	3.6 mL	7.2 mL	0.68 mL/min
>9 kg to 10 kg	114 mg / 228 mg	3.3 mL	6.5 mL	0.61 mL/min
>8 kg to 9 kg	102 mg / 204 mg	2.9 mL	5.8 mL	0.54 mL/min
>7 kg to 8 kg	90 mg / 180 mg	2.6 mL	5.1 mL	0.48 mL/min
>6 kg to 7 kg	78 mg / 156 mg	2.2 mL	4.5 mL	0.42 mL/min
>5 kg to 6 kg	66 mg / 132 mg	1.9 mL	3.8 mL	0.36 mL/min
>4 kg to 5 kg	54 mg / 108 mg	1.5 mL	3.1 mL	0.29 mL/min
>3 kg to 4 kg	42 mg / 84 mg	1.2 mL	2.4 mL	0.23 mL/min
>2 kg to 3 kg	30 mg / 60 mg	0.9 mL	1.7 mL	0.16 mL/min
>1.5 kg to 2 kg	21 mg / 42 mg	0.6 mL	1.2 mL	0.11 mL/min
1 kg to 1.5 kg	15 mg / 30 mg	0.4 mL	0.9 mL	0.08 mL/min

Administration

• These products are preservative-free and therefore, the infusion solution should be administered immediately.
  • If immediate administration is not possible, store the infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) and up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes prior to administration.
• IV bag:
  • Attach the infusion set to the IV bag. Use of in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter is strongly recommended.
  • Prime the infusion set.
  • Administer the entire infusion solution in the bag via pump or gravity over at least 16 minutes (see Table 2).
  • Once infusion is complete, flush the tubing with 0.9% Sodium Chloride to ensure delivery of the required dose.
• Syringe Pump:
  • Administer the entire contents of the syringe via syringe pump over at least 16 minutes (see Table 2).
  • After the entire contents of the syringe have been administered, flush the extension set with 0.9% Sodium Chloride to ensure delivery of the required dose.